ACTRN12616000458437已完成2 期
An Open-Label, Randomised Study of Ortho-ATI (Trademark) Versus Surgery for Treatment of Severe, Chronic, Resistant Lateral Epicondylitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 30 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Male or female aged 30-70 years of age
- •Diagnosis of lateral epicondylitis:
- •Pain over the outside of the elbow AND
- •Pain when lifting objects AND
- •Pain radiating down the forearm AND
- •Positive Mills test AND
- •Ultrasound or MRI-confirmed tendinosis
- •History of lateral epicondylitis > 6 months
- •Previously received injectable therapy but did not respond
- •Gives written consent to participate in the study
排除标准
- •Participant diagnosed with posterior inter-osseous nerve compression in the affected arm
- •Unrelated injury in the ipsilateral upper limb, including nerve compression and arthritis
- •Known hypersensitivity to the comparator product or its components or known relevant medication allergy
- •Corticosteroid or other treatment injection into relevant joint within previous 3 months
- •Prior surgical intervention for lateral epicondylitis
- •Known history of inflammatory musculoskeletal disorder (eg., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythromatosis etc)
- •Female participant who is pregnant or lactating
- •Known substance abuse
- •Participation in another study with an investigational product within 2 months of the planned first study visit
- •Clinically significant disease or other medical condition that would, in the opinion of the Investigator, compromise the safety of the participant or quality of data collected
研究者
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